UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035874
Receipt number R000040870
Scientific Title Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Date of disclosure of the study information 2019/02/28
Last modified on 2021/08/28 13:31:04

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Basic information

Public title

Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement

Acronym

Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement

Scientific Title

Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement

Scientific Title:Acronym

Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement

Region

Japan


Condition

Condition

Alcohol use disorders

Classification by specialty

Psychosomatic Internal Medicine Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to investigate the effect of whether to contributes to reduction of impulsive drinking behavior by implementing cognitive behavioral therapy with attention bias correction training for patients with impaired alcohol use

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Symptoms of Addiction
(The Alcohol Use Disorders Identification Test)
Alcohol Relapse Risk Scale
Degree of inhibition of reaction to alcohol(stop-signal task)

Key secondary outcomes

Environmental Reward Observation Scale
Acceptance and Action Questionnaire-II
Mindful Attention Awareness Scale
GHQ28
Attentional bias
(visual probe task)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

For the experimental group, we will perform a carefulness correction exercise in 6 sessions (about 20 minutes) out of all 8 programs.

Interventions/Control_2

For the control group, we will perform a carefulness correction exercise in 6 sessions (about 20 minutes) out of all 8 programs.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)
Oishi clinicPerson in hospital
(2)
Alcohol use disorders
(3)
At the time of the agreement acquisition; a person 20 years or older
(4)
The person that an agreement of study entry was provided from the person after a procedure of the informed consent

Key exclusion criteria

(1)
The person who it was judged the chief physician to have difficulty in participation in this study
(2)
The person who feels extreme sleep
shortage or fatigue at the time of
study enforcement
(3)
The person who experiences

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hironori
Middle name
Last name SHIMADA

Organization

Waseda University

Division name

Faculty of Human Science

Zip code

359-1192

Address

2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan

TEL

+81-4-2949-8113

Email

simac@waseda.jp


Public contact

Name of contact person

1st name Midori
Middle name
Last name TAKESAWA

Organization

Waseda University

Division name

Graduate School of Human Science

Zip code

359-1192

Address

2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan

TEL

+81-4-2949-8113

Homepage URL


Email

m-takesawa@ruri.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Tobacco Academic Studies Center

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Waseda University

Address

2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan

Tel

+81-4-2949-8113

Email

rinri@list.waseda.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

医療法人社団祐和会大石クリニック


Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 28 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://www.tasc.or.jp/assist/archives/2019/pdf/2020_05B.pdf

Number of participants that the trial has enrolled

7

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 03 Month 31 Day

Date of IRB

2019 Year 02 Month 28 Day

Anticipated trial start date

2019 Year 03 Month 31 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 14 Day

Last modified on

2021 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040870


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name